国金证券:第六批医用耗材国采文件发布 规则细节及报量符合预期

Core Viewpoint - The centralized procurement of high-value medical consumables, including drug-coated balloons and urological intervention materials, is expected to standardize procurement and usage behaviors, improve industry ecology, and lead to short-term price declines impacting profit margins for some companies, while benefiting leading domestic enterprises that can gain more market share through successful bids [1] Group 1: Procurement Announcement - The National Organization for High-Value Medical Consumables announced the centralized procurement document for drug-coated balloons and urological intervention materials, with submission of application materials and information disclosure scheduled for January 13, 2026 [1] - The procurement cycle will run from the actual execution date of the selected results until December 31, 2028 [1] Group 2: Demand Data - Annual demand for drug-coated balloons includes 614,778 for coronary drug-coated balloons, 6,884 for peripheral drug-coated balloons (for arteriovenous fistula dialysis access), 61,434 for peripheral drug-coated balloons (above the knee), and 7,002 for peripheral drug-coated balloons (below the knee) [2] - Annual demand for urological intervention materials includes 1,372,386 for ureteral intervention guidewires, 500,833 for ureteral intervention sheaths (without physiological pressure measurement), 49,279 for ureteral intervention sheaths (with physiological pressure measurement), 15,881 for ureteral balloon dilation catheters, 284,665 for stone retrieval baskets, 326,518 for disposable ureteral soft endoscopes (without physiological pressure measurement), 18,442 for disposable ureteral soft endoscopes (with physiological pressure measurement), and 188,317 for kidney kits [2] Group 3: Market Share and Domestic Production - The bidding results indicate that leading domestic companies have a high market share, with Lepu Medical (300003) at 16% and Shandong Jiwei (subsidiary of Blue Sail Medical, 002382) at 8% for coronary drug-coated balloons, while other companies like MicroPort and Sientra have relatively lower shares [3] - For peripheral drug-coated balloons, the top three domestic companies (Sientra, Guichuang Tongqiao, and Xinmai Medical) hold 71% of the market share, indicating that the bidding situation for leading domestic enterprises meets expectations [3] Group 4: Bidding Rules - The procurement process will classify products into A and B bidding units based on the demand from medical institutions, with the top 85% of cumulative demand entering the A unit, while others will enter the B unit [4] - The selection rules will involve multiple rounds of bidding to enhance the selection rate of enterprises, with the first rule focusing on selecting companies with the lowest bid prices [5] - If companies do not qualify under the first rule, they can re-bid under the second rule, which has specific price conditions to ensure competitiveness [6]